As tragic as the death of Dr. David Barry on Monday was, Triangle Pharmaceuticals, Inc. faces additional challenges in the year ahead beyond replacing its founder and chief executive officer.

Experts say the most significant event for the company this year will be filing for Federal Drug Administration approval to market the HIV inhibitor drug Coviracil, scheduled for third quarter.

In the last 12 months, Triangle has been fighting a David-and-Goliath like battle to see if it can get a product to market first without being eaten by the big pharmaceutical giants. According to the company’s Web site, Triangle is yet to see any revenue from the sale of drug candidates.

Two weeks ago company executives decided to terminate pursuing commercialization of a second HIV drug Coactinon. Last August, the company cut 35 percent of its staff after making a decision to delay its number one hopeful druo finish at $4.35 a share.

Approval of drug isn’t guaranteed

Stromatt confirms the key is to move forward with the filing to FDA.

“When you think that 50 percent of drugs in phase III testing fail to make it out of the gate, chances of future survival are slim.”

Bottom line: in order to become profitable, Triangle must successfully obtain regulatory drug approval, and then be able to manufacture, market and sell the product.

The pharmaceutical industry is more competitive than ever before with universities, large pharmaceuticals and private research organizations. Each is becoming aware of the commercial value in biotechnology, Stromatt explains.

“Pharmaceuticals are a high risk, high stakes, high dollar venture at best,” he says. ” Undoubtedly, he adds, expect to see continued mergers and acquisitions in this industry as a whole.

Smaller companies, who have collaborative arrangements such as Triangle with Abbott Laboratories, can prove to be lifesavers. Triangle has the opportunity to gain $85 million from Abbott Laboratories if the FDA approves the drug.

“As a small company, you don’t want to be seen as a ‘takeout’ candidate,” says Stromatt. “However, if a company has a great product that looks like it has a good chance to make it to market, the company is very attractive to large pharmaceutical companies.”

That’s why Abbott Laboratories courted Triangle; if they have another drug it’s leverage and synergy with the existing product line that says to the industry we’re stable.

“Companies like Upjohn were not lucky enough to have follow up drugs, and they are out of business today,” Stromatt adds.